Following reports of people seriously injuring themselves when sleepwalking or when driving cars while asleep or disoriented after taking sleep drugs, the U.S. Food and Drug Administration urged sleep drug manufacturers Wednesday to strengthen their package labeling to include warnings about such unconscious behavior.(File Photo) Photo Gallery>>>

BEIJING, March 15 (Xinhuanet) -- Following reports of people seriously injuring themselves when sleepwalking or when driving cars while asleep or disoriented after taking sleep drugs, the U.S. Food and Drug Administration urged sleep drug manufacturers Wednesday to strengthen their package labeling to include warnings about such unconscious behavior.

    The FDA will also require additional warnings of the potential for allergic reactions with the use of the drugs.

    Rosalind Cartwright, a professor and chair of the department of psychology at Rush University in Chicago, has been a sleep researcher for 40 years and experienced firsthand last September the potential affects of the sleeping pill Ambien when mixed with an over-the-counter cold medicine.

    "That night, I have no idea what happened, except that I found myself on the floor at 3:30 a.m.," she says. "I was really hurt badly, but I crawled back into bed and went to sleep."

    When her alarm sounded three hours later, she discovered she was bleeding and in serious pain.

    She says a trip to the emergency room revealed that during the night she had somehow managed to sustain four pelvic fractures, three broken ribs, a fractured left wrist and a nasty bump on the head that led to bleeding on her brain.

    Cartwright says she doesn't have personal or family history of sleepwalking. She believes an interaction between the sleeping pill Ambien and an over-the-counter cold medicine she had taken earlier that night caused her to leave her bed and injure herself.

    The side effects of the drug made national headlines on May 5, 2006, when Rhode Island Rep. Patrick Kennedy smashed his Ford Mustang into a barrier near Capitol Hill. He later released a statement saying he had been disoriented by two prescription medications he had taken, one of which was Ambien.

    Additionally, the FDA has uncovered more than a dozen reports of sleep driving, all linked to the drug.

    Sleeping pills, in general -- and Ambien, in particular -- have come under increasing scrutiny over the past year.

    A class action lawsuit against the maker of Ambien, Sanofi-Aventis, was filed on March 6, 2006 by those claiming they engaged in a bizarre variety of activities while asleep such as binge eating and driving after taking the drug.

    Physicians say though Ambien, Lunesta, Rozerem and similar sleep drugs are still safe in most cases, the stronger labeling is a step in the right direction.

    "All effective drugs always have side effects, some of which can be potentially harmful," says Dr. Emmanuel Mignot, professor of psychiatry and behavioral sciences at the Stanford University School of Medicine.

    "As these are discovered or even suspected, it is best to err on the side of caution so that the public and doctors can appropriately react if these side effects do occur."

    Even as the FDA advocates stronger labeling, the agency maintains sleeping drugs do not pose enough of a health hazard to warrant pulling them off pharmacists' shelves.

    (Agencies)